A Phase 0 Open Label, Single-center Clinical Trial of ABY-029, an Anti-EGFR Fluorescence Imaging Agent Via Single Intravenous Injection to Subjects With Operable Head and Neck Cancer.

The investigators plan to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of operable head and neck cancer in this open label, single center, clinical trial of ABY-029.

Administration of ABY-029 will occur as a single intravenous injection to subjects with operable head and neck cancer approximately 1-3 hours prior to surgery.

Documentation of the tumor with digital photography will be performed at several time points during surgery: pre-resection, at intermediate time points during surgery, and post-resection. White light assessment of the tumor and boundaries will be performed by the surgeon.

Intraoperative optical probe measurements will occur in areas of visible tumor as well as normal appearing tissue. At multiple time points during each surgery and at the discretion of the surgeon, optical probe measurements will be completed with the probe followed by biopsy sampling of the same sites when they are intended for resection. Commonly, these acquisitions will occur at first exposure of the tumor, at the approximate mid-point of tumor resection (when a significant amount of tumor tissue is present in the operative field), at a point nearing but prior to completion of tumor resection (when a small amount of tumor tissue is presumably present), and at the intended completion of tumor resection (when residual tumor may or may not exist). At a data collection time point, optical probe measurements will be performed and archived for analysis and locations may be biopsied when tissue is intended for resection.

Any normal tissue removed as part of surgical procedure will be sampled. Samples may be taken from tissue outside the "antic" tumor volume but resected as part of the procedure along the surgical corridor. All tissue collected will be submitted to pathology for routine processing.